FDAFDA · Food and drugs·Recall number Z-0188-2018
Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 140 mm in length in the native Superficial Femoral Artery (SFA) and/or proximal popliteal arteries with reference vessel diameters ranging from 4.5 - 7.5 mm.
Published December 6, 2017 · Recall initiated: November 3, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Stent length on the label may not match the length of the stent itself.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Inc.
- Distributor
- Nationwide Distribution to AZ, CA, GA, IA, IL, KY, MA, NC, NE, SC, TN, VA
- Lot
- Model No. EVD35-07-060-120, UDI 00821684051436, Lot No. A476328. Model No. EVD35-07-120-120, UDI 00821684051467, Lot No. A476301.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.